Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
NCT00275379
Last updated date
ABOUT THIS STUDY
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design,
exploratory study of orally administered ERB-041 in subjects with active IC. The primary
objectives of this study will be to investigate ERB-041's activity on levels of urinary APF,
explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to
evaluate the safety of ERB-041 in women with active IC.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Interstitial Cystitis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC
- Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Use of herbal supplements (except for a daily multivitamin/mineral supplement not
containing herbal components)
- History of cancer (other than resected cutaneous basal or squamous cell carcinoma or
in situ cervical cancer) with less than 5 years documentation of a disease-free state
- Vaginitis or vaginal infection within 1 month before randomization
NEED INFO?
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Advanced Information
| Descriptive Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis | |||||||||
| Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis | |||||||||
| Brief Summary | This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered ERB-041 in subjects with active IC. The primary objectives of this study will be to investigate ERB-041's activity on levels of urinary APF, explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to evaluate the safety of ERB-041 in women with active IC. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||||||||
| Condition ICMJE | Cystitis, Interstitial | |||||||||
| Intervention ICMJE | Drug: ERB-041 | |||||||||
| Study Arms ICMJE | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Withdrawn | |||||||||
| Actual Enrollment ICMJE | 0 | |||||||||
| Original Enrollment ICMJE | 60 | |||||||||
| Study Completion Date ICMJE | Not Provided | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||
| Sex/Gender ICMJE |
| |||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Austria, Germany, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00275379 | |||||||||
| Other Study ID Numbers ICMJE | 3142A4-109 B2381036 ( Other Identifier: Pfizer ) | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
| |||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Verification Date | September 2020 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||